Authorization for batch release of biological products expanded, accelerating product launch timelines.
Release date:
2023-03-02
To enhance the efficiency of batch release for biological products (vaccines), the National Medical Products Administration has decided, based on a thorough risk assessment, to gradually expand the scope—both in terms of provincial drug regulatory agencies authorized to conduct inspections and testing, and in the types of biological products (vaccines)—involved in the batch-release process.
To enhance the efficiency of batch release for biological products (such as vaccines), the National Medical Products Administration has decided, based on a thorough risk assessment, to gradually expand the scope—both geographically and in terms of product types—to include more provincial drug regulatory agencies and testing institutions authorized to carry out vaccine batch releases. For seasonal influenza vaccines and other similar products, the batch release timeline will be shortened to within 45 working days. This initiative will effectively reduce the time vaccines and other biological products spend waiting to enter the market, ensuring a steady supply. For vaccine manufacturers, faster market access will boost operational efficiency, enabling companies to deliver products more promptly. Ultimately, this move will also help improve the timeliness and coverage of vaccination programs in China, providing stronger safeguards for public health security.
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